Recruiting

Cognitive Behavioral Therapy & Inhibitory Control Training

Sponsor:

Drexel University

Code:

NCT04076553

Conditions

Binge-Eating Disorder

Bulimia Nervosa

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Interventions

CBT

ICT

Study Details

Brief summary:

The primary aim of this study is to determine whether a computerized inhibitory control training (ICT) will improve CBT treatment outcomes for Bulimia Nervosa and Binge Eating Disorder.

Conditions

Binge-Eating Disorder

Bulimia Nervosa

Study ID

NCT04076553

Start date

Oct 15, 2019

Status verified date

Aug, 2021

Completion date

Jul, 2022

Anticipated

Primary completion date

Jul, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • age 18-55
  • meet DSM-5 criteria for Bulimia Nervosa (i.e., at least one episode of binge eating and compensatory behavior per week on average for the past 3 months) or Binge Eating Disorder (i.e., at least one episode of binge eating per week on average for the past 3 months).
  • be stable on psychiatric medications for at least 3 months

Exclusion Criteria:

  • have a diagnosis of anorexia nervosa or a BMI < 18.5
  • have extreme malnutrition or other medical complications that require acute hospitalization
  • are at acute suicide risk
  • are currently experiencing other severe psychopathology that would require a more intensive or specialized treatment program than the current study provides (e.g. severe depression, active psychotic disorder)
  • have previously completed a trial of CBT for Bulimia Nervosa or Binge Eating Disorder
  • have a diagnosis of an intellectual disability or autism spectrum disorder
  • currently taking stimulant medications
  • score of 95% or higher on 550ms block of Go/No-Go assessment task, indicating high inhibitory control at Baseline

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: CBT + ICT

Participants randomized to the ICT condition will complete a computerized ICT training at home during the first 4 weeks of treatment and ICT "boosters" following their treatment sessions during weeks 5-12.

sham comparator: CBT + sham

Participants randomized to the sham condition will complete a computerized sham ICT training at home during the first 4 weeks of treatment and sham ICT "boosters" following their treatment sessions during weeks 5-12. The shame will contain the same proportion of food as non-food but no inhibitory training component.

Interventions

CBT

Participants will complete 12 sessions of CBT

ICT

Participants will complete 4 weeks of daily inhibitory control trainings and "booster" ICT trainings following CBT treatment in weeks 5-12

Primary outcome measure

  • Eating Disorder Examination (EDE) [ Time Frame: Change in binge frequency from baseline to post-treatment and 3-month follow-up ]

Central Contacts and Locations

Central contacts

Lindsay Gillikin, BA

215-553-7110EDresearch@drexel.edu

Locations

Drexel University

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Lindsay Gillikin, BA

215-553-7110EDresearch@drexel.edu

More Information

Sponsor

Drexel University

Last update posted

Aug 9, 2021

Last verified

Aug, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Drexel University on 2021-08-09.